NCT06800443

A Cosmetic Study to Measure the Change in Tooth Colour After Using Instant Whitening Prototypes Compared to a Negative Control

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Unilever R&D · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This will be a double blind, randomised, four-group crossover study. This study will involve 5 visits to the study site, with a wash-out period of 1 week between visits. Visit 1 will be for screening, participants who meet inclusion and exclusion criteria (including having Vita shade score of 2M2, 3R1.5, 2R2.5, 3L1.5, 2L2.5, 4M1, 2M3, 3M2, 4R1.5, 4L1.5, 3L2.5, 3R2.5, 5M1, 4M2, 3M3 from VITA 3D-MASTER Shade Guide) will be accepted onto the study. At each test visit (visit 2 - 5), participants will have images taken of their front upper incisors using a a Video-based Digital Imaging System (VDIS) pre- and post-brushing with randomly allocated test or control toothpaste \[1.5g for 90 seconds, followed by water rinse\]. The digital images will be analysed using the VDIS image analysis software and the mean CIELAB and WIO of the upper central incisors will be obtained.

Conditions

• Tooth Color

Interventions

Type	Name	Description
OTHER	Silica-based fluoride toothpaste containing clay, charcoal, blue covarine and green covarine	Silica-based toothpaste containing charcoal, clay, blue covarine, green covarine and fluoride as sodium fluoride
OTHER	Silica-based fluoride toothpaste with blue covarine	Silica-based toothpaste containing lower level of blue covarine and fluoride as sodium monofluorophosphate
OTHER	Silica-based fluoride toothpaste with blue covarine	Silica-based toothpaste containing higher level blue covarine and fluoride as sodium monofluorophosphate
OTHER	Control silica-based fluoride toothpaste	Control silica-based toothpaste containing fluoride as sodium fluoride

Timeline

• Start date: 2018-12-03
• Primary completion: 2019-01-04
• Completion: 2019-01-04
• First posted: 2025-01-30
• Last updated: 2025-01-30

Locations

1 site across 1 country: China